Director of Regulatory Affairs
8 days ago
Slough
Blackfield Associates are seeking a Regulatory Affairs Director to lead lifecycle regulatory activities for a large established products portfolio. This role is pivotal in ensuring compliance with European regulatory requirements, developing and implementing regulatory strategies and continued portfolio expansion via acquisition. Key Responsibilities: • Develop and implement EU regulatory strategies for established products., • Lead and manage interactions with regulatory authorities across EU and UK., • Drive lifecycle management activities including authoring and submission of variations, such as Type 1,1b, Type 2 variations, safety updates, SmPC and Package Leaflet changes, • Collaborate cross-functionally with KOLS, • Monitor and respond to regulatory changes in global markets, sharing insights and best practices., • Lead and coach Regulatory Professionals, setting clear objectives and fostering development aligned with company goals. Qualifications & Experience: • Significant (Minimum 8 years) experience managing lifecycle regulatory activities for established products in Regulatory, • Previous held Regulatory management positions such as Lead or Associate Director, • Strong expertise in authoring and submitting regulatory variations, including safety and quality-related changes., • Advanced degree in a life science discipline desirable, • In-depth knowledge of EU and UK regulatory procedures (MRP/DCP/CP and NP)., • Proven experience in technology and marketing authorisation transfers., • Experience gained in a fast paced environment, • Familiarity with CMC and clinical variation classifications and submission requirements., • Experience working in a matrix environment with cross-functional collaboration., • Strategic thinker with the ability to navigate complex regulatory landscapes., • Previous line management experience would be desirable, • Must be a clear, concise communicator This is a full time permeant position. Hybrid working. Unable to sponsor, all applicants must hold valid right to work in the UK and have the ability to attend the office.